The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Sidekick Rail Fixator.
| Device ID | K080071 |
| 510k Number | K080071 |
| Device Name: | SIDEKICK RAIL FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Peggy S Rivers |
| Correspondent | Peggy S Rivers WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-11 |
| Decision Date | 2008-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420141248 | K080071 | 000 |
| 00840420127273 | K080071 | 000 |
| 00840420127280 | K080071 | 000 |
| 00840420127297 | K080071 | 000 |
| 00840420127303 | K080071 | 000 |
| 00840420128980 | K080071 | 000 |
| 00840420129000 | K080071 | 000 |
| 00840420129017 | K080071 | 000 |
| 00840420129024 | K080071 | 000 |
| 00840420129031 | K080071 | 000 |
| 00889797066716 | K080071 | 000 |